1-Year Safety and Effectiveness of a Next-Generation Dual-Seal Left Atrial Appendage Occluder

Left atrial appendage occlusion (LAAO) is a stroke prevention alternative for patients with atrial fibrillation (AF) intolerant to long-term oral anticoagulation (OAC). The next-generation dual-seal device was designed to improve operator ease of use while maintaining effective LAAO of the predicate device.

The purpose of this analysis was to evaluate the safety and effectiveness of a next-generation device through 1 year.

VERITAS is a single-arm, prospective, global, multicenter study. Patients with nonvalvular AF with an increased thromboembolism risk seeking a nonpharmacologic alternative to OAC were enrolled. One-year descriptive endpoints are provided, including mortality, neurological events, major bleeding, and device-related complications. One-year cardiac imaging was assessed for peridevice leak and device-related thrombus (DRT).

Complete left atrial appendage (LAA) closure (0 mm leak) was observed in 91.1% (95% CI: 87.9%-93.7%) of patients by either transesophageal echocardiography (TEE) or cardiac computed tomography and 96.3% (95% CI: 93.2%-98.2%) by TEE alone. The cumulative DRT rate was 3.3% (95% CI: 2.0%-5.3%) with only 0.4% (95% CI: 0.1%-1.5%) deemed clinically relevant. One-year key clinical outcome rates are as follows: all-cause mortality: 3.9% (95% CI: 2.4%-6.3%); cardiovascular mortality: 1.9% (95% CI: 0.9%-3.8%); major bleeding: 6.6% (95% CI: 4.5%-9.2%); ischemic stroke or systemic embolism: 1.8% (95% CI: 0.8%-3.3%); pericardial effusion requiring intervention: 0.9% (95% CI: 0.3%-2.1%). No (0%) device embolization occurred. Median follow-up was 365 days (IQR: 349-380 days).

The VERITAS study results support the 1-year safety and effectiveness of the next-generation device. (Abbott Medical-VERITAS Study; NCT06707688).